AccessGUDID - DEVICE: CamX Spectra Caries Detection Aid (D678G41000)

GUDID

Device Identifier (DI) Information

Brand Name: CamX Spectra Caries Detection Aid
Version or Model: G4100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678G41000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33995	Dental caries detector, optical induced fluorescence	A mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBL	Laser,Fluorescence Caries Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090169	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3992f2f-b115-43d0-88be-03c7ba1a054b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2016